510(k) K262144
K262144 is an FDA 510(k) premarket notification submitted by SETAGAYA SEIKI Co., Ltd. for the device "DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece". The FDA issued a decision of Substantially Equivalent on Sep 23, 2026. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 23, 2026
- Date Received
- Jun 25, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)